Highly efficient breastpump and system for expressing breastmilk

ABSTRACT

The present invention provides a breastshield for use in a breastpumping system for expressing milk, the breastshield being of such a construction that substantially limits the amount of air between the breast/nipple and the breastshield surrounding the breast/nipple, and most preferably virtually eliminates any air at least in the area of the breast and nipple. In some embodiments, any air in the breastpumping system is substantially eliminated. With the amount of air limited, the mechanism used for generating the pressure difference in the breastshield (e.g., vacuum or negative pressure), such as a diaphragm pump, does not need to do as much work. Less energy is required for the expression of milk, and thus the size of pump used can be decreased, thereby reducing the overall cost of the device.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/428,459, filed Feb. 9, 2017, which is a divisional of U.S.patent application Ser. No. 12/885,145, filed Sep. 17, 2010, now U.S.Pat. No. 9,603,982, which claims priority to provisional applicationSer. No. 61/244,636 filed on Sep. 22, 2009. This application is alsorelated to U.S. patent application Ser. No. 13/742,502, filed Jan. 16,2013. The entire disclosure contents of these applications are herewithincorporated by reference into the present application.

FIELD OF THE INVENTION

The invention relates generally to breastmilk pumps, and particularly toan improved breastpump assembly for expressing mothers' milk, which inone significant aspect, substantially eliminates any “dead volume” inpumping, especially in the area of the breast and nipple.

BACKGROUND

Breastpumps are well known, and generally are comprised of breastshields(also referred to as hoods) that fit over the breast, a vacuum pumpconnected to the breastshield for generating an intermittent vacuumwithin the breastshield, and a receptacle for the milk that is pumpedfrom the breast. Manually driven vacuum pumps are commonplace, as wellas those that are driven by a motor (house current, battery, pneumatic,etc.).

The vacuum pumps of these devices intermittently generate a vacuum (ornegative pressure) within the breastshield, with the breastshieldcovering the nipple and typically a substantial amount of the breastitself. The intermittent suction action of the pump serves to pull onthe nipple, and so express milk, in an action that some have consideredsimilar to suckling. The milk so extracted ordinarily flows from thebreastshield into a collection container, e.g., a bottle, for storageand later use. A breastpump of the foregoing description is shown inU.S. Pat. Nos. 4,857,051, and 4,929,229, and reference thereto may bemade for further detail on breastpumps in general. A recent advancementin these types of breastpumps is also disclosed in US Patent Publication2008/0171970.

Breastshields typically have a funnel-shape, comprising a conicalportion with a tubular extension, the latter sometimes referred to asthe nipple tunnel. The nipple and surrounding breast are received in theconical portion, with the nipple often extending into the tubularextension. Under vacuum, the breast is pulled further into thebreastshield, ordinarily with the nipple then being pulled into thetubular extension, with the surrounding breast thereby also typicallybeing pulled further into the funnel.

A nursing mother's nipples may thus be forced against the wall of thenipple tunnel under vacuum. This may cause friction against the wall asthe nipple moves deeper into the nipple tunnel. There can also befriction between the breast and the conical portion, as well as in thenipple tunnel. This is actually a back-and-forth movement under theintermittent vacuum, exacerbating the effects of the frictionalengagement.

Researchers, particularly those working with Medela, have studied themanner in which infants breastfeed, and have come to seriously questionthe “conventional wisdom” on how a baby feeds from the breast. Forinstance, it appears that a vacuum instead of a stripping action isoccurring during milk expression. Further, nipple placement is proximalto the hard/soft palate junction rather than at the junction. Ultrasoundimaging shows that there is little to no air in the natural “system”when the infant is nursing. In other words, when the infant is latchedonto the mother's breast, there is little to no air in the infant'smouth. The suckling action by the baby seems to radially compress aswell as expand (or release some compression) the nipple; the nippleattempts to expand into the volume created as the baby's tongue movesaway from the palate.

In contrast, in commercially available breastpumps used by mothers forexpressing or extracting breastmilk for later use by the infant, air ispresent in the system, specifically in the breastshield into which thebreast is placed. Once a mother's breast is in place, the pump must worknot only to express the breastmilk from the breast but also must work tomove the air in the system as well. This, understandably, affects thesize of the pump, and the energy required to make the pump work.

Another observation of researchers is that, during nursing, the babylatches onto the mother's breast and the baby's tongue has continualcontact and interacts with the nipple of the breast to bring about theflow of milk. In commercially available pumps, once the breast isinserted into the breast cup or shield, the vacuum generated by the pumptypically pulls the breast further into the breastshield, ordinarilywith the nipple then being pulled deeper into the tubular extension. Thenipple tends to be more or less “free” within the nipple tunnel, exceptto the extent it may be pulled into contact with the nipple tunnel wall(or expands to fill the tunnel diameter because of the applied vacuum).When compared to nursing, the expression of milk with a breastpump ofthis conventional design can bring about some discomfort to the mother,and does not entirely duplicate the feel and conditions present innormal suckling.

Further, with the available breast pumps, a mother generally is in asubstantially vertical position while pumping, and the bottle into whichthe breastmilk flows must be located in a position downwardly from themother. This is because conventional breastpumps operate using gravityas the prime mover to move milk from the breastshield to the bottle.This limits the mother's activities while pumping; for example, shecannot recline to any great extent while pumping.

SUMMARY

Embodiments of the present invention provide a breastshield for use witha breastpump for expressing milk, the breastshield being of such aconstruction that substantially limits the amount of air between thebreast/nipple and the breastshield surrounding the breast/nipple, andmost preferably virtually eliminates any air at least in the area of thebreast and nipple. With the amount of air limited, the mechanism usedfor generating the pressure difference in the breastshield (e.g., vacuumor negative pressure), such as a diaphragm pump, does not need to do asmuch work. Less energy is required for the expression of milk, and thusthe size of pump used can be decreased, thereby reducing the overallcost of the device.

The vacuum pump can therefore be configured to be smaller and lighter,which means that it is in turn less conspicuous to onlookers. The mothercan use the vacuum pump more discreetly. In addition, because of thelower energy, the vacuum pump is quieter during use, which in turnincreases the comfort and discretion.

One aspect of the small working volume of the invention includesutilizing sensing of the vacuum pressure applied to the nipple andprocessing the vacuum level reading, as through a microprocessor controlsystem, for example. The microprocessor then drives the pump in a mannerto ensure the appropriate vacuum profile is produced at the nipple. Thiswill allow the invention to perform consistently from mom to mom andwill also allow for an improved reproduction of vacuum profiles of aninfant. A vacuum regulator could similarly be used. Such sensing orregulation could further be useful in maintaining a baseline vacuum orminimum vacuum at the nipple, which remains throughout the pumpingsession.

Movement of the nipple can thereby be limited, and the amount of air inthe system reduced or virtually eliminated, especially in embodiments ofthe present invention for the expression of milk including a baselinevacuum. A baseline vacuum would be one that is maintained during some orall of a pumping session, such that the pressure seen at the nipple doesnot return to ambient, but remains at, say, a pressure of approximately−20 to −50 mmHg, before returning to a greater vacuum during milkextraction. Reference can be made to U.S. Patent Publication No.2008/0255503 entitled “Method and Apparatus for Minimum NegativePressure Control, Particularly For Breastpump With Breastshield PressureControl System,” filed on Apr. 11, 2007, which is incorporated byreference herein in its entirety, for further detail on such “baselinevacuum.”

Further, with the breastshield of the present invention, vacuum may acton a smaller portion of the mother's breast, indeed on the nipple alone,as compared to known breastshields. Specifically, the breastshield ofthe present invention in one aspect constrains the nipple of the breast,and provides contact surrounding a significant portion or substantiallyall of the nipple, more closely duplicating conditions in normalbreastfeeding.

The reduction of air in the area of the nipple, or further in the entiresystem can range from substantially no air (“zero dead volume”), orsubstantially no air after initialization (i.e., air is largely orcompletely eliminated in the working volume after one or more initialcycles); or a small volume of air remains, but still achieving one ormore of the inventive objectives. This reduction of air can consist ofan initially larger opening which subsequently conforms more closely tothe nipple to reduce the air volume around it. Embodiments include, butare not limited to, the use of inflating seals, self expanding seals,fit adjustment mechanisms, as well as custom fit openings.

In an embodiment of the invention a vacuum is applied just to the end ofthe constrained nipple. Embodiments for the constraint of the nippleinclude either longitudinal, radial, or both radial and longitudinallimitation to nipple movement. Such constraint will limit the expansionof the nipple from applied negative pressure, resulting in improvedcomfort. Again, as used herein, this “expansion” could be an extensionof the nipple from its rest shape, or in the sense of going from acompressed condition to a less compressed condition.

Another attribute or aspect of the invention is providing embodimentsthat closely surround the nipple and adjacent breast with part of alateral sidewall (or walls) of the breastshield that are designed to bereminiscent of the tongue of the baby. That is, this sidewall structureis then made to move radially relative to the breast/nipple. This inturn moves the breast/nipple outwardly (i.e., expanding it), which isbelieved to be much more like what an infant's suckling actually does.

Several embodiments of the invention include the use of low durometermaterials to simulate the soft tactile feel and function of the insideof a baby's mouth.

As well, this invention comprises embodiments where a separate suctionsource or sources may be applied to the end of the nipple for theexpression of milk. In this aspect the constraint of the nipple servesto provide the benefits of comfort and tactile sensation, as well asprovide a sealing element at the base of the nipple to further reducethe working volume of air.

In an aspect of the invention, more of a radial force is applied to thenipple than a longitudinal force, i.e., the nipple is subjected to aforce that tends to enlarge the nipple radially, and then compress orreturn the nipple as the breastshield returns to an initial condition.This expansion of the breastshield can be used to create the suctionpressure to express milk, reducing or eliminating the need for a secondvacuum source.

Several embodiments of the invention include an expansion of the nippleduring the vacuum rise portion of a vacuum cycle. When the vacuum isreturned to an ambient or baseline level, the nipple is relaxed or evensomewhat compressed.

An embodiment of the invention includes not expanding the nipple beyondits natural diameter.

Another aspect of the invention is an apparatus and method for improvedbreastfeeding by compressing the nipple asymmetrically, i.e.,out-of-round. In a conventional pump, the nipple is drawn into astructure (e.g., nipple tunnel) which has a circular cross-section. Itis considered an advantage herein to provide a structure where thenipple is subjected to a radial force that presses it into a moreelliptical cross-section.

In addition to the lateral or longitudinal constraint described above,an aspect of the invention includes the further constraint of the nipplefrom lateral movement, including utilizing a physical constraint ofmovement at the distal end of the nipple. The location of this physicalend constraint can be adjusted to an individual. The end constraint mayfurther consist of a porous cover to allow milk and pressure transferthrough it, such as a porous membrane, valve, or orifice structure.

While an objective of the invention is to minimize the “dead volume,”with some embodiments even substantially eliminating “dead volume”throughout the entire system, it is readily apparent that the inventiondescribed has advantages not limited to the foregoing, such that thesystem might have a large or typical air volume away from the proximallocation of the nipple, but just include the elements of nippleconstraint to gain the benefits of comfort and effective milkexpression.

Embodiments of the invention can also readily utilize any of the nipplecontact surfaces to provide a tactile stimulation to the nipple, furtherimproving comfort and enhancing milk ejection. This includes the use oftactile features on the contact surfaces, and alternately includesdriving of the contact surfaces with a force to apply a stimulation tothe nipple, either in sync with or unrelated to the vacuum cycle.

In addition, due to the substantial elimination of air from the systemof the present invention, the mother is not required to be in asubstantially vertical position while expressing milk; further thecontainer into which the expressed breastmilk flows does not need to belocated downwardly with respect to the mother. An embodiment providesfor a system which actively forces liquid to move, and is not reliant ongravity. The expressed milk moves through the breastpump assembly to thecontainer provided, regardless of its location with respect to themother. This provides flexibility for the mother in the type ofactivities in which she can participate while expressing milk. It alsoallows the breastpump assembly conduit structure, and even the containerinto which the expressed milk is collected, to be located other thandownwardly with respect to the mother's breast. As well, the containermay be of a type, such as an expandable container, that is normallyclosed or compressed and can be expanded by the expelled milk as thecontainer is filled. As a result, the milk can be expressedindependently of the relative orientation of the breastshield, the milkcollecting container, and the vacuum pump with respect to one another.The mother may, for example, even express milk while lying down. This isparticularly optimal in a “hands-free” embodiment since the mother mayeven bend down and in general move more freely.

Another embodiment of the invention has the mother's milk routed, atleast in part, into the channel through which the vacuum, or workingfluid, is initially operating on the breastshield. The milk therebyreplaces the “air” (vacuum) in this part of the system, turning it froma pneumatic system to a hydraulic system. This is considered to increasethe efficiency. That is, this reduces the work that the pump needs to doto achieve the effective vacuum level, and thus increases the efficiencyof the system. A further salutary benefit is that the mother's own milkcan now be used to warm the shield.

Another embodiment of the invention utilizes a sheath-like membranewhich is emplaceable over a funnel-shaped or other breast-receivingshaped shield part, thereby forming a liner to the shield part. Thesheath-like membrane is adapted to closely surround the nipple,achieving objectives of greatly eliminating air volume surrounding thebreast/nipple and improved tactile sensation. The sheath-like membranecan also be made disposable, providing an additional benefit.

These as well as other aspects and advantages of the invention willbecome further apparent to those of skill in the art by reading thefollowing detailed description, with reference where appropriate to theaccompanying drawings. It should be understood that the embodimentsdescribed herein are intended to illustrate the invention by way ofexample only, and are not limiting.

BRIEF DESCRIPTION OF THE FIGURES

Exemplary embodiments of the invention are described herein withreference to the drawings, in which:

FIG. 1 is a perspective view of an embodiment of the present invention;

FIG. 2 is a side elevational view of the breastshield part shown in FIG.1;

FIG. 3 is a front end view of the breastshield shown in FIG. 2;

FIG. 4 is a front end view of the breastshield shown in FIG. 3, with asheath partly detached from the breastshield;

FIG. 5 is a sectional view in elevation of an embodiment like that ofFIG. 1;

FIG. 6 is a schematic view in section showing another embodiment of theinventive breastshield using two sources of pressure (here, vacuum);

FIG. 7 is a schematic view in section of yet another embodiment of theinventive breastshield showing a system having a valve member capable ofmaintaining a baseline vacuum in the breastshield;

FIG. 8 is yet another embodiment of the inventive breastshield insectional view;

FIG. 9 is a front end view of the breastshield of FIG. 8;

FIG. 10 is a rear end view of the breastshield of FIG. 8;

FIG. 11A is a modified version of the embodiment of FIG. 8;

FIG. 11B is another modified version of the embodiment of FIG. 8;

FIG. 12 is still a further embodiment of the inventive breastshield insectional view;

FIG. 13 is a rear end view of the breastshield of FIG. 12;

FIG. 14 is another embodiment of the inventive breastshield in sectionalview, shown in a first position;

FIG. 15A is a partial view of the embodiment of FIG. 14 in a secondposition;

FIG. 15B is a view like that of FIG. 15A, showing the valving in aninverted (upward) position, and with a pressure sensor;

FIG. 16 is still another embodiment, this one shown schematically insection and elevation;

FIG. 17 is the embodiment of FIG. 16, with a nipple ring being enlarged;

FIG. 18 is a figure similar to that of FIG. 16 of an embodiment having anipple cap carried by a movable wall;

FIG. 19 is the embodiment of FIG. 18 with the nipple cap attached aboutthe nipple;

FIG. 20 is yet another embodiment using a figure like that of FIG. 18,employing a nipple cap and a nipple cover;

FIG. 21 is a schematic of a drive mechanism for use with thebreastshield shown in FIG. 14; and

FIG. 22 is another example of a drive mechanism for use with thebreastshield shown in FIG. 14.

DETAILED DESCRIPTION

FIG. 1 depicts a first system for expressing breastmilk in accordancewith the present invention. The system includes a breastshield 10attached to a base 12. Base 12 is part of a breastpump assembly moreparticularly shown in US Patent Publication 2008/0171970, the disclosureof which is incorporated herein by reference. That assembly includes avacuum pump which utilizes a barrier component (see FIG. 5) or diaphragm14 that is enclosed in a clamshell-like chamber made of a front housing18 and a rear housing 16. The barrier is reciprocated within the spaceof the housings 16, 18 by an intermittent vacuum from a vacuum source(not shown) which is connected via a tube 20 (see FIG. 1). Movement ofthe barrier downstream by the vacuum source conveys vacuum upstream byits movement (expanding the volume upstream).

Milk extracted in operation flows to a container 22 attached to a collar24 which communicates with conduit structure within the breastshieldassembly. Again, the details of this breastshield assembly andbreastpump can be gleaned from the foregoing patent publication. As willbe well appreciated, this embodiment using the foregoing pump of FIGS.1-5, while substantially eliminating any residual air in the immediatevicinity of the nipple, as will be shortly described in detail, stillwill contain a volume of air on either side of the barrier (diaphragm),and especially in the tubing extending to the vacuum source. The presentinvention not only contemplates substantially eliminating the “deadvolume” of air at the nipple, but in other embodiments (see, e.g., FIGS.14, 15A, 15B and FIGS. 21-22), the virtual elimination of the “deadvolume” in the entire system.

As can be seen in FIG. 1 and in further detail in FIGS. 2 and 5, thebreastshield 10 includes a funnel or conical portion 26, a tubularextension or nipple tunnel 28 extending therefrom, and a valve 30provided at the downstream end of the tubular extension 28. The termsfunnel and conical are being used herein with reference to the moretraditional shapes of breastshields, which are adapted to receive thenipple and surrounding breast therein. As is evident herein, however,the breast receptacles of many of the embodiments no longer employ atrue “funnel” or “cone” geometric shape.

The lack of a large volume funnel accommodates a wide range of breastsizes and types and minimizes the potential dead volume in the funneland nipple tunnel area. The valve 30 used in this version is a duckbillvalve. It is mounted in a solid ring 32, which closes the end of thetubular extension 28.

The breastshield of the present invention is further provided with asheath-like member 34, which functions in part as a liner for the funnelpart of the breastshield 10 (portion 26 and nipple tunnel 28). Thesheath member 34 has a rim part 36 that fits around and secures thewidened mouth of the sheath member to the outer circumference of a rim38 of the shield portion 26 (see FIGS. 3 and 4 in particular). Shieldportion 26 and nipple tunnel 28 thereby form a frame for the sheathmember 34.

The sheath member 34 is connected at its downstream end 40 about theupstream end of the duckbill valve 30, sealing around that valve on adownstream edge surrounding the valve. As can be seen in FIG. 5 inparticular, the sheath member 34 is also somewhat funnel-like in shape,being placed into some stretched tension (i.e., taut) through theforegoing mounting arrangement. This serves to pull the sidewalls of thesheath member 34 away from the inner sidewall 42 of the breastshield 10(much like stretching an unfilled balloon). The sheath receives thenipple of the breast in use, and snugly holds the nipple and someadjacent breast in a supple embrace. The sheath 34 is made of siliconerubber in a relatively thin thickness, again, much like a thick balloon.As can be seen from FIG. 4, the sheath can be easily removed from thebreastshield, being shown partially peeled back from the underlyingshield to which it is mounted. This provides an additional benefit, inthat the sheath member 34 can be made disposable.

Note that in this embodiment, the sheath member 34 yields a nipplereceiving inner tunnel 44 which is out-of-round, i.e., not of a circularcross section (see FIG. 3). Here, it is somewhat elliptical. Thisprovides a radial force to the nipple which tends to flatten the nippleon opposite sides, toward an elliptical shape.

It will be noted that FIG. 5 has a slightly different shape from that ofFIGS. 1-4 in the area of the portion 26. This simply shows anapplication that is more of the traditional conical or funnel-shape forthe breast-receiving part of the breastshield.

During expression, the breast, and primarily the nipple of the breast,is inserted into the mounted sheath member 34. Vacuum is applied fromthe vacuum source (pump) via the tube 20, with the vacuum conveyed tothe breastshield by action of the barrier 14 within the clamshell-likechamber. The vacuum evacuates an antechamber 46 within the base 12, andis further conveyed into the space 48, thereby forming a plenum betweenthe sheath member 34 and the inner sidewall 42 of the shield via achannel 50. As can be appreciated from FIGS. 2 and 5, the vacuum is thusapplied on the distal end of the nipple via outward radial movement ofthe sheath member 34 as it expands, and through the valve 30. This inturn pulls upon the nipple constrained in the sheath member. Thisapplies, in part, an outward force (referred to herein as “radial”). Thesheath member 34 substantially limits the amount of air in the system.Essentially, there is only air initially located between the nipple andthe valve that is involved, along with air in the antechamber 46.

Milk expressed into the downstream end of the sheath member 34 passesthrough the duckbill valve 30, where it is conveyed through internalconduit structure to the bottle 22. Note that the duckbill valve can bestructured so that a preset vacuum level is maintained within the sheathmember, such as at a minimum pressure (vacuum) of approximately −20 to−50 mmHg, for instance. A one-way duck bill valve 30 is used herein, butother equivalent types of valves can be used. Again, reference can bemade to U.S. Publication No. 2008/0255503 regarding such a “baseline”vacuum concept and its effectuation.

FIG. 6 is yet another embodiment of a system for expressing breastmilkthat uses two sources of pressure, here vacuum. The system includes abreastshield 52 which would be attached to the base 12 of FIG. 1. Base12 is part of a breastpump assembly more particularly shown in US PatentPublication 2008/0171970, described above with the first embodiment.Milk extracted in operation flows to the container 22 attached to acollar which communicates with conduit structure within the breastshieldassembly. Again, the details of this breastshield assembly andbreastpump can be gleaned from the foregoing patent application.

As can be seen in FIG. 6, this embodiment of the invention has abreastshield 52 with a receptacle portion 54, an inner side wall 55, atubular extension or nipple tunnel 56, and a downstream end 66 with aplurality of openings 58. This embodiment has an outer sidewall 60 thatis somewhat rigid (or relatively less collapsible than the innersidewall 55, as will hereafter be made apparent). For example, the innersidewall 55 could be similar to the foregoing sheath-like member 34.There is a first port 62, and a second port 64. The inner sidewall 55includes the downstream end 66.

The first port 62 and the second port 64 are provided on the portion 54.The first port 62 is in communication with the antechamber 46 of thebase 12, and a first vacuum source. The second port 64 is connected to asecond vacuum source. The vacuum sources could be from a common vacuumgenerator and modulated, for instance, and need not be two separatesources.

The first vacuum evacuates the antechamber 46 within the base 12(referring back to detail of the first embodiment), and is furtherconveyed through port 62 into the nipple tunnel 56 between the sidewallsof the breastshield 52. The first vacuum is applied to the breastshield52 for a longitudinal force (axial) and for transporting the milkexpressed from the nipple. Next, the second vacuum is applied from thesecond vacuum source, for radially pulling on the inner sidewall 55.This in turn radially pulls upon (or expands/decompresses) the nipple,which is constrained and embraced by the inner sidewall 55. Milkexpressed into the downstream end 66 passes through the plurality ofopenings 58, where it is conveyed through internal conduit structure tothe bottle 22.

As can now be seen, when a vacuum source is applied to the port 64 toyield a pressure less than that of in the nipple tunnel 56, the innersidewall 55 expands, applying an outboard radial force to theencompassed nipple. When the vacuum levels near equilibrium, or thenipple tunnel goes more negative than the space 57, the resilient innersidewall returns to its rest state or even compresses. It will be notedthat this embodiment could so be adapted to apply an inboard force byhaving the vacuum between the sidewalls be such that the vacuum at firstport 62 is greater than that between the sidewalls, thus in essenceyielding a more “positive” pressure being applied about the nipple.

Here, again, the inner sidewall 55 substantially limits the amount ofair in the system.

Those of skill in the art will appreciate the embodiment illustrated inFIG. 6 is not limited by the order the first vacuum source and thesecond vacuum source are applied to the breastshield 52. In analternative embodiment, the second vacuum source is applied to thebreastshield 52 before the first vacuum source is applied to thebreastshield 52. In another embodiment, both the first vacuum source andthe second vacuum source are simultaneously applied to the breastshield52.

FIG. 7 is still another embodiment of a system for expressing breastmilkshowing a system having a valve member capable of maintaining a baselinevacuum in the breastshield. As can be seen in FIG. 7, the breastshield70 includes a receptacle portion 72, an inner sidewall 74, a tubularextension or nipple tunnel 76, a valve 78, an outer sidewall 80, and avacuum inlet 82.

In the breastshield 70, the tubular extension 76 extends from thereceptacle portion 72. The valve 78 is provided at the downstream end ofthe tubular extension 76, communicating with antechamber 46 of the base12 (again, refer to the base and related structure of FIGS. 1 and 5).The vacuum inlet 82 is between the antechamber 46 and the space 57between the sidewalls.

The inner sidewall 74 is, at its downstream end of the tubular extension76, sealed about the upstream end of the valve 78, which here is aduckbill valve. As in the embodiment of FIG. 6, the inner sidewall 74 ispulled away from the nipple when a vacuum is applied between thesidewalls which is more negative (greater vacuum) than that in thenipple tunnel 76.

Of course, this is simply a function of pressure (or force) differentialas between the tubular extension and the space 57. Those with skill inthe art will recognize many ways to generate the desired pressure orforce differential for movement of the inner sidewall 74 besides whathas been specifically described with respect to FIGS. 6 and 7.

In operation, the inner sidewall 74, which is preferably made ofsilicone rubber in a relatively thin thickness, receives the nipple of abreast and snugly holds the nipple and some adjacent breast in a suppleembrace.

Vacuum is applied from the vacuum source, which is preferably a pump,via the tube 20, with the vacuum conveyed to the breastshield both atthe antechamber 46 (downstream of the valve 78) and at the inlet 82.While a common negative pressure is being applied both downstream of thevalve 78 and at the inlet 82, the valve 78 is designed to operate suchthat the vacuum in the space 57 between the sidewalls goes more negativethan that in the nipple tunnel for a brief period. This applies theradial pull on the nipple, as the nipple tunnel 76 expands. Ultimately,the vacuum pressure causes the valve 78 to open, so milk passes throughthe valve 78, and is transported to the milk container 22.

Various breastshields disclosed herein may be used with a vacuum pump asshown and described in a PCT application no. PCT/CH2010/000225, entitled“Device and Method for Expressing Human Breastmilk,” filed on Sep. 17,2010. Vacuum pumps for use in breastpumping are, however, well known.

The valve 78 also can serve to yield a baseline vacuum being maintainedin the nipple tunnel 76, closing at a predetermined negative pressure,as previously described with relation to the first embodiment above. Abaseline vacuum would be one that is maintained during some or all of apumping session, such that the vacuum seen at the nipple does not returnto ambient, but remains at, say, a pressure of approximately −20 to −50mmHg, before returning to a greater vacuum during milk extraction. Thoseskilled in the art will appreciate the benefits of maintaining abaseline vacuum during operation. For example, milk expression should bemore comfortable to the mother.

FIGS. 8 through 10 show yet another embodiment of a system forexpressing milk. The breastshield 84 is preferably molded in silicone,in large part, and is somewhat flexible. It has an outer wall 86, aninner wall 87, an upstream turned out rim 88 forming an opening, adownstream end 89, and an inner sidewall 90. A tubular extension ornipple tunnel 92 is thereby defined. A valve 94 is mounted on a dividingwall 91, which extends transversely across the nipple tunnel, at a pointwhere the nipple will preferably not impact the wall in any deleteriousmanner during pumping. The downstream end 89 connects to the antechamber46 of the base 12, for example (see FIGS. 1 and 5 regarding the base 12and related structure).

Inboard of the sidewall structure 90 is a thin flexible member 95, whichextends across a quadrant of the upstream part of the nipple tunnel, infront of the wall. The thin flexible member 95 at its downstream end issealed to the dividing wall 91. This creates a bladder structure ormember, which is preferably designed to be reminiscent of the tongue ofa baby. There is a slot 93 in the wall 91 which communicates with theinterior of the foregoing bladder. The slot 93 conveys vacuum pressureto the bladder interior. While a slot 93 is shown, it could be greatlyexpanded in this area, for ease in manufacturing.

Reminiscent of the embodiment of FIG. 7, a negative pressure (vacuum)applied at the end 89 initially generates a pressure differentialbetween the area of the nipple tunnel 92 within which the nipple isreceived and surrounded, and the interior of the bladder. This causesthe member 95 to move radially outboard (or outward) relative to thenipple and the breast. This in turn pulls the nipple outwardly, and thencontracts when the member 95 returns to its initial position. Responsiveto this action, the nipple expresses milk. Milk expressed into thedownstream end of the tubular extension 92 passes through the valve 94,which is preferably a duckbill valve, where it is conveyed throughinternal conduit structure to the bottle 22. Note that these types ofbreastshield shapes of FIGS. 6-10 for instance, serve to best positionthe nipple therein, thereby further facilitating a minimization of anyresidual air volume.

Turning now to FIG. 11A, this is a modified version of the breastshieldof FIGS. 8 through 10. This breastshield 96 has a member 95′ thatradially extends farther into the tubular extension 92 than the member95 of breastshield 84 of FIG. 8. Dividing wall 91′ is moved moredownstream, with its duckbill valve 94.

FIG. 11B is a variation of what has been described with respect to FIG.11A. Here, the bladder or tongue member 95″ is now separated from thesidewall structure 90, and is much more like the forward part (free end)of a baby's tongue. What is particularly novel with this embodiment isthat, when negative pressure (vacuum) is released downstream of thebreastshield 96 (upon completion of the vacuum cycle), member 95″actually initially expands within the extension 92 (given the pressuredifferential that then exists between the member and the interior of theextension 92). Note that the embodiment of FIG. 11A could also providethis feature.

FIGS. 12 and 13 illustrate still another embodiment of a system forexpressing milk. This time, the breastshield 98 assumes a relativelyrigid more funnel-shaped construct, with a receptacle portion 100 havinga more traditional circular cross section nipple tunnel 101 downstreamthereof. There is an inner side wall 102 to the funnel, an upstream edgeor rim 104 defining the widened opening for the portion 100, and adownstream end 105.

Fitted inside of the funnel is a flexible liner 106, which can be asheath-like member previously described. Liner 106 has a rim 107 whichis formed with an outer lip that is turned inwardly to form an annularchannel around the circumference of the rim 107. This channel isdesigned to more or less snap fit around the rim 104 of the conicalportion, to fix the liner 106 at the upstream end. At the downstream endof the liner 106, a knob 112 is formed. That knob 112 fits through anaperture of an endwall 109 that extends across the end 105 of the nippletunnel, and is thereby held in place. The spacing between the rim 104and the endwall attachment of the liner 106 is such that the liner 106may be, or preferably is stretched, and pulled taut when attached withinthe funnel. The shape of the liner 106 is also funnel-like, but resultsin a space (plenum) 108 being formed between the inner sidewall 102 ofthe funnel and the outside of the liner 106. Note that the downstreamend 105 has a plurality of slots 111 for fluid conveyance (fluid beingboth milk and vacuum). The liner 106 includes one (or more) lateralopenings 110 at the knob 112, which operates much like the foregoingduckbill valves.

In operation of the breastshield 98, liner 106 is mounted inside of thefunnel (portion 100 and nipple tunnel 101) so that sidewalls of theliner 106 are pulled away from the inner sidewall 102. The nipple andbreast placed in the liner 106 are thus closely embraced. The vacuum isapplied from the vacuum source, which is preferably a pump, via the tube20, with the vacuum conveyed to the breastshield 98. The vacuum causesthe liner 106 to expand into the space between the inner sidewall 102,in turn applying a radial outward force to the nipple. Milk expressedinto the downstream end of the sheath-like member 106 passes through thelateral opening 110 where it is conveyed through the plurality of slots111 of the endwall 109, then through internal conduit structure to thebottle 22.

FIGS. 14 and 15A show yet another embodiment of a system for expressingbreastmilk. The system includes a breastshield 114 which isfunnel-shaped, having a receptacle portion 116, from which extends asomewhat tubular extension or nipple tunnel having a first part 124.This nipple tunnel is formed as an extensible chamber, however, withanother part indicated at 128. The function of this extensible nippletunnel will shortly be described.

Located within the receptacle portion 116 and extending into the nippletunnel is an inner liner part 126. The inner liner part 126 is fixed atits upstream end to the inner wall of the receptacle portion. Itsdownstream end 132 extends inboard from the sidewall, and is spaced fromthe walls defining the tubular extension. Its downstream end 132 has aplurality of openings 138 for fluid flow.

There is a duckbill valve 122 connected to the nipple tunnel. That valvecommunicates with conduit structure leading to a milk container, orcould directly pass to the bottle.

There is a hinge-like structure 130 formed as a bend between the twoparts of the nipple tunnel 124, 128. The distal end of the nipple tunnelis closed at 120, with a knob formed thereon. With an axial forceapplied to the knob 120 to move it toward (direction 136) and then awayfrom (direction 134) the distal end of the liner part 126 (therebyreciprocating part 128 of the nipple tunnel), the volume of the nippletunnel 124, 128 is caused to contract and expand. This initiallygenerates an intermittent vacuum (negative pressure) within thebreastshield 114 (more so in the area around the nipple).

The nipple is constrained in the liner part 126 within the nippletunnel. Milk expressed by this reciprocating action flows through theopenings 138, into the nipple tunnel 124, 128 and then through the valve122. FIG. 15A illustrates the nipple tunnel being compressed in thedirection 136. After milk is expressed, it collects in the nipple tunnel124, 128. On the next stroke, the milk is pushed through the valve 122,which is preferably a duckbill valve, where it is conveyed throughinternal conduit structure to the bottle 22.

Of further interest in this embodiment is that the milk thereby replacesthe initial working fluid of the reciprocating pump formed by theexpansible nipple tunnel, going from air to milk (liquid). The systemthus goes from pneumatic system to a hydraulic system, increasingefficiency. Moreover, the mother's own milk can now be used to warm thebreastshield 114, which makes the mother more comfortable during milkexpression, and research has demonstrated increases milk flow rate.

In this embodiment, we now can see how the air or “dead volume” isvirtually eliminated within the entire system. FIG. 15B is intended tofurther show this, illustrating how the valve 122 can be orientedupwardly (relative to ground), or in virtually any other position, sincegravity is no longer the prime (or only) mover of the milk. Tubing orother conduit structure (not shown) would surround the valve 122, forexample, to convey milk to a container. Milkflow is thus effected by thepumping action of the reciprocating parts of the nipple tunnel 124, 128,and is independent of gravity. This by itself is considered to be ahighly significant advance in breastpumping. The entire breastpumpassembly has furthermore become extremely compact and efficient.

FIG. 15B also illustrates the additional feature of applying a pressuresensor S to the system. This sensor would be used to monitor thepressure being applied at the nipple providing a signal to a controllervia electrical connection 133, for setting a desired maximum pressurefor instance, or perhaps as well a desired minimum (referring back tothe “baseline” pressure concepts discussed above). Use and applicationof such a pressure sensor or pressure transducer is disclosed in U.S.Publication No. 2008/0255503.

The breastshield 114 disclosed in this embodiment would use a rotarydrive mechanism 200, such as in FIG. 21. The drive mechanism 200 has aring 201 within which the breastshield 114 is maintained. Ring 201 hasinternal threads. Received within the ring 201 is a rotary drive member202, which is externally match-threaded to the ring 201. A conventionalmotor 204 is schematically illustrated, and connects through aconventional drive train to the drive member 202 to thereby rotate thedrive member 202, relative to the ring 201. The knob 120 of thebreastshield 114 is mounted within an orifice of the drive member 202.When the drive member 202 is turned in one direction, it moves outwardlyrelative to the ring 201, thereby extending the nipple tunnel 124, 128.When drive member 202 is rotated in the opposite direction, it movesinwardly relative to the ring 201, compressing the nipple tunnel.

Another example of a drive mechanism which may be used with thebreastshield 114 and substantially eliminate “dead volume” throughoutthe entire system is shown in FIG. 22. This type of drive mechanism mayinclude a piston lever arm system 300, and is further described in U.S.Pat. No. 7,223,255, issued on May 29, 2007, entitled “System for aPortable Hands-Free Breast Pump and Method of Using the Same,” which isherein incorporated by reference in its entirety. The breastshield 114would be adapted to fit the general makeup of the piston lever armsystem 300. The knob 120 of the breastshield 114 connects to a pistoncylinder 306. The piston lever arm system 300 includes a servomotormechanism 302 connected to a lever arm 304. The lever arm 304 is used toadjust the piston cylinder 306. The servomotor mechanism 302 pivotallymoves the lever arm 304, which then linearly moves the piston cylinder306 to move the knob 120, in and out in a linear fashion, to therebyextend and compress the nipple tunnel 124, 128.

FIGS. 16 and 17 illustrate still another embodiment of a system forexpressing breastmilk. The breastshield 140 includes an upstream cone142, a nipple tunnel 144, and an inflatable chamber or bladder 146. Thecone 142 and nipple tunnel 144 yield a funnel-shape.

As can be seen in FIG. 16, the inflatable chamber 146, which ispreferably toroidal, is coupled to the cone 142 and the nipple tunnel144 at substantially the area of transition in the funnel to the nippletunnel 144. The nipple tunnel 144 is in communication with a vacuumsource (not shown). The inflatable chamber 146 is in communication witha pressure source (not shown).

In operation, the funnel receives the nipple 153 of a breast 150 andsnugly holds the nipple 153 and some adjacent breast. In this embrace,the distal end of the nipple 153 extends into the nipple tunnel 144.Next, as can be seen in FIG. 17, the inflatable chamber 146 expands andgrows in size. The inflatable chamber 146 preferably expands in responseto a pressure applied by the pressure source. When expanded, theinflatable chamber 146 contacts the breast. The inflatable chamber 146preferably contacts the breast at substantially the area of transitionfrom the areola to the nipple 153. The nipple 153 further extends intothe nipple tunnel 144 in response to the breast being contacted by theinflatable chamber 146.

Next, a vacuum is applied by the vacuum source, which the nipple tunnelconveys to the nipple 153. The nipple surface area that the vacuum isconveyed to is minimized when the inflatable chamber 146 contacts thenipple (and any adjacent breast). In response to the vacuum action, thenipple 153 expresses milk. The milk flows through the nipple tunnel 144and through a conduit structure to a container (not shown). Minimizingthe breast area and surrounding open volume that the vacuum mustinteract with increases efficiency.

FIGS. 18 and 19 show yet another embodiment of a system of expressingmilk. The breastshield 154 includes a cone 156, a nipple tunnel 158, anda flexible membrane 161. The flexible membrane 161 is preferably foldedupon itself. A cup 160 has a sealing ring 164, a distal or downstreamend 166, and an opening 168.

In the breastshield 154, the cone 156 and nipple tunnel 158 define afunnel shape. The nipple cup 160 is in communication with a vacuumsource (not shown). The flexible membrane 161 is located in the nippletunnel 158. Membrane 161 is connected to the nipple cup 160, and is alsoconnected to the nipple tunnel inner wall. Due to the connections of thestretchable membrane 161, the stretchable member is configured to movein the nipple tunnel 158. The sealing ring 164 is connected to thenipple cup 160. The sealing ring 164 is located inside the nipple cup160 upstream of both the distal end 166 and the opening 168. The opening168 is connected to an internal conduit structure, which is in turn isconnected to a container (not shown), for milk flow. A one-way valve(not shown) may be placed at or beyond opening 168 to provide one-wayair or milk flow through the tubing 175.

In operation, the funnel receives the nipple 173 of a breast 170 andsnugly holds the nipple 173 and the adjacent breast. The nipple 173extends into the area 162 within the nipple cup 160. The nipple cup 160can expand both laterally and radially to receive the nipple 173. Thenipple cup 160 expands to receive the nipple in response to thetranslation of the flexible, preferably stretchable, membrane 161 withinthe nipple tunnel 158. Due to the translation of the membrane 161, thenipple cup 160 is configured to receive nipples of varying diameter andvarying length, thereby minimizing system volume.

As can be seen in FIG. 19, the distal end of the nipple 173 extends pastthe sealing ring 164. In this configuration, the flexible membrane 161laterally seals the nipple 173, which minimizes the nipple surface areato which a vacuum force is to be applied.

Next, a vacuum may be applied by the vacuum source through a hose ortube 174, and the vacuum is conveyed to the distal end 166 of the nipplecup 160. In response to the vacuum, the nipple cup 160 applies a forceto the nipple 173. In response to the applied force, the nipple 173expresses milk, and the milk flows through the opening 168 into tubing175 and through the internal conduit structure to the container.

FIG. 20 is still another embodiment of a system for expressingbreastmilk. The breastshield 176 includes an upstream cone 178, adownstream nipple tunnel 180, nipple cover 182, a collar 184, and a cap186. The cap 186 includes an opening 188. The cap 186 is much like thatpreviously described with respect to the embodiment of FIGS. 18 and 19.

In the breastshield 176, the nipple cover 182 is attached at itsupstream end to the cone 178, and the nipple cover 182 extends into thenipple tunnel 180. The collar 184 is located around the nipple at itsbase and functions much like an O-ring. The collar 184 is preferablyconnected to the inner wall of the nipple tunnel 180. The cap 186 isconnected at its upstream end to the nipple cover 182. The opening 188is located on the cap 186, and the opening 188 is connected to tubing198 and then to an internal conduit structure, which is in turnconnected to a container (not shown), for milk flow. Alternatively, themilk outflow could go directly into a container. A one-way valve (notshown) may be placed at or beyond opening 188 to provide one-way air ormilk flow through the tubing 198.

In operation, the funnel receives the nipple 194 of a breast 190 withthe nipple 194 extending into the cap 186. In this configuration, thenipple cover 182, which is preferably a plastic film that is fluidpermeable, or which has small openings in it, covers the nipple 194, andthe collar 184 closes the nipple cover 182 against the breast. Thecollar 184 preferably contacts the breast 190 at substantially the areaof transition from the areola to the nipple 194. When the vacuum sourceapplies a vacuum through tube 196, the vacuum generates a force appliedto the nipple covered by the nipple cover 182. In response to theapplied force, the nipple 194 expresses milk. As can be seen in FIG. 20,the milk flows through the nipple cover 182 to the opening 188.

While certain features and embodiments of the present application havebeen described in detail herein, it is to be understood that theapplication encompasses all modifications and enhancements within thescope and spirit of the following claims.

The invention claimed is:
 1. A breastshield assembly, comprising: abreastshield having a receptacle portion coupled to a nipple tunnel, avalve coupled to the nipple tunnel, and inner liner configured to beplaced within the breastshield; and a drive mechanism having a housinghaving a ring or cylindrical shape, wherein the breastshield is at leastpartially contained within the housing; wherein the breastshieldassembly and the drive mechanism are configured to cause a volume of thenipple tunnel to contract and expand to initially generate a negativepressure through the use of air as an initial working fluid, causingmilk to be expressed after milk is expressed, the expressed milkcollects in the nipple tunnel thereby replacing the initial workingfluid with the expressed milk and creating a hydraulic system whichgenerates subsequent pressure in the breastshield.
 2. The breastshieldassembly of claim 1, wherein the valve communicates with a conduitstructure leading to a milk collection container.
 3. The breastshieldassembly of claim 2, wherein the valve is oriented upward relative tothe ground.
 4. The breastshield assembly of claim 3, wherein the valveis a duckbill valve.
 5. The breastshield assembly of claim 3, furthercomprising a container within which expressed breast milk is received,wherein the container is located anywhere other than downwardly withrespect to the nursing mother's breast, such that expressed milk doesnot enter the container from the nipple tunnel under the action ofgravity.
 6. The breastshield assembly of claim 1, wherein the nippletunnel is formed as an extensible chamber.
 7. The breastshield assemblyof claim 6, wherein the nipple tunnel has a hinge in the form of a bendbetween a first part and a second part of the nipple tunnel therebypermitting a volume of the nipple tunnel to contract and expand.
 8. Thebreastshield assembly of claim 6, wherein the distal end of the nippletunnel is closed and coupled to a knob configured to be acted upon by anaxial force.
 9. The breastshield assembly of claim 6, wherein the innerliner has an upstream end coupled to an inner wall of the receptacleportion and has a downstream end extending inboard from the inner wallof the receptacle portion, wherein the downstream end of the inner linerhas a plurality of openings.
 10. The breastshield assembly of claim 1,wherein the inner liner has a rim coupled to an upstream edge of thereceptacle portion and has a downstream end coupled to an end wall thatextends across the end of the nipple tunnel such that a space is formedbetween an inner sidewall of the breastshield and an outside of theinner liner.
 11. The breastshield assembly of claim 10, wherein the endwall of the nipple tunnel has a plurality of slots configured for fluidconveyance.
 12. The breastshield assembly of claim 10, wherein the innerliner is configured to expand in response to a vacuum thereby applying aradial force to at least one of a nipple or a breast received within theinner liner.
 13. The breastshield assembly of claim 10, wherein thedownstream end of the inner liner has one or more openings.
 14. Thebreastshield assembly of claim 13, wherein the one or more openings atthe downstream end of the inner liner have the form of a duckbill valve.15. The breastshield assembly of claim 1, wherein the breastshield andthe drive mechanism are arranged to permit the second working fluid towarm the breastshield.
 16. The breastshield assembly of claim 1, whereinthe housing has a cylindrical shape, wherein the drive mechanism is apiston lever arm system arranged such that the breastshield is coupledto a piston cylinder that is coupled to a lever arm that is coupled to aservomotor to thereby extend and compress the nipple tunnel.
 17. Thebreastshield assembly of claim 1, wherein the housing has a ring-shapeand the drive mechanism has a rotary drive member coupled to the housingvia matching threads such that the rotary drive member is rotatablerelative to the housing.
 18. The breastshield assembly of claim 1,wherein at least a minimum negative pressure is maintained in thebreastshield throughout repeated cycles during a pumping session.